DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin

• Status: Completed
• Trial end date: 2017-12-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the impact of itraconzaole on the pharmacokinetics of Dorzagliatin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hua Medicine Limited
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

Inclusion Criteria:

• Age 30-65

• Body weight ≥ 50 kg

• BMI ≥ 19.0 kg/m2 and ≤ 30.0 kg/m2

• HbA1c ≥ 7% and ≤ 10.5%

• FPG ≥ 7.5 mmol/L and ≤ 13.3 mmol/L

Exclusion Criteria:

• T1DM

• Use of prescription or OTC medications, and herbal within 14 days prior to dosing

• Blood donation

• Any surgery or treatment that may impact the ADME of the drug